PrimeTaper 68011090Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper Surgical Tray · Class 2
Quick summary
This Dentsply PrimeTaper surgical tray is listed as a sterilization accessory. Reports mostly describe dental implants failing to bond and coming loose, sometimes with bone loss, infection, inflammation and pain. There are 23 reports naming its identifier, with no deaths and 23 injuries. No recalls name this device, with recent reports rising from 6 in the previous year to 17 in the last year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07392532253010), received between Feb 4, 2025 and Aug 12, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate21
- Loss of Osseointegration2
Patient problems
- Failure of Implant23
- Osteolysis4
- Unspecified Infection3
- Inflammation2
- Implant Pain1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50222073 ↗InjuryAug 4, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50129427 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced dental implant loss due to inflammation and pain three months after placement.
Patient problems: Failure of Implant; Implant Pain; Inflammation
MAUDE report 50009483 ↗InjuryJul 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25839266 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25818937 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25818915 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25818880 ↗InjuryJun 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FAILURE.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 25673236 ↗InjuryMar 25, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24683795 ↗InjuryFeb 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24230773 ↗InjuryJan 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24175537 ↗InjuryJan 21, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24136780 ↗InjuryJan 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED UNSPECIFIED INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24000638 ↗InjuryDec 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23858561 ↗InjuryDec 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23858557 ↗InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552536 ↗InjuryNov 10, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23514512 ↗InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23376101 ↗InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23376099 ↗InjuryOct 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT LOOSENING AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23331602 ↗InjurySep 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23096822 ↗InjuryJul 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22665317 ↗InjuryFeb 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21303292 ↗
Other Sterilization wrap containers, trays, cassettes & other accessories devices
- None 400498Intuitive Surgical, Inc. · Sterilization wrap containers, trays, cassettes & other accessories1 recall2 reports
- V. Mueller CD4-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-61B-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD3-4STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- AESCULAP US751Aesculap, Inc. · Sterilization wrap containers, trays, cassettes & other accessories50 reports
- V. Mueller CD5-3B-REDCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3STCarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
- V. Mueller CD5-3C-PURPLECarefusion 2200, Inc · Sterilization wrap containers, trays, cassettes & other accessories1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.